) tested direct-to-consumer ads for its BRACAnalysis, a genetic test that measures a woman's risk for breast and ovarian cancer based on mutations in certain genes.
Ads for pharmaceuticals are commonplace in the mass media, but Myriad's experiment, though on a small scale, marked the first time a "predictive medicine" test was marketed to a broad consumer audience. It won't be the last, however. It's still early days for the field of genomics -- the study of genes and their roles in disease -- yet significant changes in medicine as a result of genomics are all but certain in coming years. With change, no doubt, comes pressure from companies for the right to air many more ads for genetic tests like the one Myriad did. If Myriad's experience is any indication, the ethically tricky task of marketing the tests responsibly isn't insurmountable.
The Centers for Disease Control (CDC) initially had doubts about the Myriad ads. Given that the genetic mutation that BRACAnalysis tests for occurs in only a small percentage of women with breast or ovarian cancer, the CDC feared that the ads could unnecessarily worry the general public. So it decided to survey doctors and consumers after the campaign. "The issue is, should you do mass marketing for something that occurs in just a percentage of the population?" says Melanie Myers, public-health geneticist at CDC and lead investigator on the survey. The survey looked at awareness of the tests and the campaign's impact in the test cities compared to similar-size cities Raleigh-Durham and Seattle, where the ads weren't aired.
DOCTORS WITHOUT ANSWERS. The results, recently published by the CDC, painted a mixed picture. Consumer awareness of the diagnostic test was substantially higher in the pilot cities than in control cities, though the majority of both sets of respondents said they knew little or nothing about such diagnostics. The number of women who had talked with doctors or others about the test and their level of concern about risk for breast and ovarian cancer were about the same in both pilot and control cities.
The upshot is that no flurry of inappropriate testing followed the airing of the ads, according to the survey. However, physicians surveyed in the test cities did report more patients asking about testing and counseling. They also reported ordering more tests. Doctors, however, generally came up short in their knowledge of the genetic test. Many were "not able to address complexities around the test," says Myers.
Myriad's marketing experiment provides a glimpse of how difficult it'll be for companies to convey complex information about genetic testing. For one, the campaign proved that by the very nature of mass-market media such as TV and radio, Myriad had little control over who sees and doesn't see the advertising. Bill Rusconi, Myriad's marketing head, says that by featuring women talking about family members with breast and ovarian cancer, the ads were designed to draw the interest of women with a family history of the cancers. Myriad will not provide details on how many of the women tested in the pilot cities were appropriate, but Rusconi says women with family history who requested testing outnumbered those without by 2 to 1.
NOT EXACTLY LINING UP. Ads that target women with family history of the cancers may still cast too wide a net, says Muin J. Khoury, director of the CDC's Office of Genomics & Disease Prevention. Some 10% to 20% of women have a family history of breast and ovarian cancer, but only about 1% of all women should consider getting BRACAnalysis at all, Khoury says.
Moreover, how people deal with information from a test like BRACAnalysis, which has been around since 1996, will remain controversial. It has served as a preview of the kinds of difficult questions that patients and doctors will have to face when such tests become standard. Testing positive with BRACAnalysis is a solid indication that lifetime risk of ovarian and breast cancer is substantially higher. But there's no guarantee that a positive test means a woman will get either cancer.
"When this test became available, the assumption was that the buzz among women was going to be very strong," says Dr. Barron Lerner, historian and internist at Columbia University Medical Center. But it didn't happen that way. "I suspect some women just don't want the knowledge of future risk."
"BULLETPROOF LEGISLATION." The business of selling predictive diagnostic tests remains in its infancy. Myriad is the most visible player, with tests for hereditary colon cancer, melanoma, endometrial cancer, and pancreatic cancer. In the fiscal year ending June 30, 2003, it reported $34.6 million in revenues, a 29% rise from the previous year, for its predictive-test business, the bulk of which came from BRACAnalysis sales.
Myriad calls the advertising a success, though it has no immediate plans to expand it to a national level, says Rusconi. A broader campaign may not be worth the cost considering the limitations. Among them: not enough genetic counselors in the health-care system to appropriately guide patients who seek testing. Physicians, too, are generally not well-informed about who should and shouldn't receive testing and counseling.
It's clear that regulation of genetic tests and their advertising will have to be developed as scientists uncover more genetic markers of disease susceptibility. Rusconi believes that legislation banning genetic discrimination could make people less fearful of taking the tests. The Senate passed such a bill this year, and the House is now debated it. "Bulletproof legislation will really help reduce that fear," Rusconi says.
Still, figuring out how to appropriately market the tests will be a huge challenge. Myriad's experience shows it may be doable -- but only after a lot more experimentation. Tsao is a reporter for BusinessWeek Online in New York